Various types of tests related to patient diagnosis and therapy can be performed by analysis for an analyte within a sample of a patient's infections, bodily fluids or abscesses. Patient samples are combined with various assay reagents in reaction vessels; the mixture is then incubated and analyzed using interrogating radiation measurements to aid in treatment of the patient. Automated clinical analyzers for chemical, immunochemical and biological testing of such sample-reagent mixtures are well known, typically adding one or two assay reagents to a liquid sample, the reagents being obtained from reagent storage compartments maintained on-board the analyzer.
For convenience and compactness within an automated chemical analyzer, it is desirable to store all reagents needed to conduct a single assay within contiguous compartments or vessels. Typical of such vessels is the multi-compartment reagent container available for use in an analyzer known as the Dimension® Chemical Analyzer, sold by Dade Behring Inc., Deerfield, Ill. This multi-compartmented container is in the form of a container strip described in U.S. Pat. No. 4,720,374, entitled “Container Having a Sonication Compartment”, issued to Ramachandran, and includes a rigid peripheral band formed of an inert plastic. The band is formed integrally with each of several reagent containers so that the container strip generally tapers in a substantially elongated wedge-like manner from a first edge to a second edge. The wedge-shaped plan profile for the container strip facilitates the mounting of a plurality of such strips in a circumferentially adjacent generally radially extending relationship across a rotatable reagent carrying plate, like described in U.S. Pat. No. 4,863,693, entitled “Analysis Instrument Having A Blow Molded Reaction Chamber”, issued to Howell, and having a reagent supply arrangement with an array of multi-compartment reagent containers disposed in substantially radial directions from the vertical center of rotation of rotatable plate. The reagent containers may be refrigerated or cooled, if desired, as is discussed therein. The reagent supply includes a reagent dispensing probe that is movable in substantially radially inward or radially outward directions with respect to the plate to aspirate a selected reagent from any one of the segmented reagent compartments of the multi-compartment reagent containers and to deposit a predetermined amount of reagent into one or more of a number of reaction vessels disposed at angular positions arranged around the periphery of the plate.
The tops of the multi-compartment reagent containers may be sealed with a suitable laminate that prevents gas and vapor escape and yet permits penetration by a probe for aspiration etc. The plastic used for the receptacle is polyethylene and the laminate is a three-ply laminate of a polyester film, a polyvinylidene chloride coating on the polyester film, and finally a sheet of polyethylene adhered to the coating. The laminate is heat sealed to the peripheral surface of the polyethylene compartments with the lower polyethylene sheet contacting the compartment rim. Variations of such a multi-compartment reagent container are described in U.S. Pat. Nos. 4,935,274 and 5,009,942 all of which are assigned to the assignee of the present invention.
A persistent problem with the use of reagent containers as employed on automated clinical analyzers is accidental attempts to re-use reagent containers that have been previously used on such an analyzer. When a container is used on an analyzer, partial amounts of reagents are removed by reagent aspiration devices; if the container is removed from the analyzer, it is possible that reagent quantities remaining therein may become contaminated or stored in a hostile environment so that their reactive characteristics become altered. In such instances, erroneous analytical results may be reported by the analyzer before the situation is noted and corrected. Accordingly, it is desirable whenever a reagent container is initially placed onto an analyzer, that an automated method be provided to determine whether the container is new and unused or whether the reagent container has been previously used.
U.S. Pat. No. 5,976,469 discloses an analytical specimen cup having a removable lid of a type for defining a test space with a chemical strip mounted therein; the cup includes a selectively-removable protective cover for selectively covering and uncovering an outer surface of a transparent portion of an outer partition forming the test space. The protective cover is formed as one piece with an inner partition to be attached thereto by a dual living hinge. The lid is rectangular in shape and includes an elongated magnifying lens which has protrusions extending into blind holes of the inner partition. The magnifying lens extends across the transparent portion of the outer partition. When the protective cover is in a closed position it impinges on the magnifying lens.
U.S. Pat. No. 5,645,824 discloses a color changing reagent composition for coating onto syringe needles and other needle containing medical devices which upon contact with such bodily fluids as blood, mucous, saliva, and semen will cause the composition coated needle to change in color to signal a prior use and contamination with a possibly infected bodily fluid.
U.S. Pat. No. 5,472,415 discloses an instrument for evaluating the fit of a corresponding orthopedic implant. The instrument is intended and designed to be a disposable, single use provisional instrument component. The provisional instrument component is made of a material which can be sterilized by gamma irradiation, but which provides a visible indicator, such as visible deformation, upon re-sterilization by exposure to a heated environment, thereby discouraging or preventing re-use of the component.
U.S. Pat. No. 5,403,551 discloses an assaying device for both collecting and analyzing a sample which includes a container and an opening for collecting the sample in a chamber for storing the sample. A cap is provided for sealing the container opening and at least one assay system is attached to the container for chemically analyzing the sample. A channel is provided for enabling a portion of the sample to enter the assay system upon a change of orientation of the container. A tamper-proof device is provided through the use of a releasable seal which permits the sample to enter the assay system only when desired.
U.S. Pat. No. 5,255,804 discloses a tamper-proof closure for a tube includes a neck projection on a neck of the tube, which neck projection is riveted to an edge of a sleeve section provided in a cap. After the neck projection has been broken off to use the tube, the cap can be replaced on the tube, however, the connection is so loose that when the tube is picked up again, the cap is immediately detached from the neck, thus indicating prior use.
U.S. Pat. No. 4,591,062 discloses a tamper-evident closure apparatus for internally pressurized containers includes a closure provided with a mechanism for venting the internal pressurized gas upon initial unsealing of the container and a tamper-indicating device adapted to be acted upon by the vented gas to indicate that an initial unsealing of the container has occurred. The tamper-indicating device may be, for example, chemically activated to change colors when acted upon by the vented gas or may be mechanically activated so that venting of the pressurized gas causes a visibly apparent disruption, distortion or the like to indicate initial unsealing of the container.
U.S. Pat. No. 4,286,640 discloses a tamper-resistant cover for the port of a container for medical liquids which when applied to the port indicates that an additive material has been introduced into the container. The port cover is molded from a resinous plastic material and includes latch portions which fit into a latch bar with the latch bar serving as a means to prevent access with the latch portions so as to result in a tamper-resistant structure. The latch portions are in the form of barbed sections and are guided by means of an inclined ramp into latch openings in such a manner that a compression fit is provided so that after the barbed sections are forced through the latch openings the barbed sections will expand to engage latch surfaces in the latching bar.
From this discussion of the state of art in automated clinical analyzers, it may be seen that while there has been progress toward introduction of tamper-evident containers, there has been no progress made toward reducing the potential problems caused by re-use of a clinical assay reagent container. Thus, there remains an unmet need for a method and reagent container adapted to disable an analyzer whenever a previously used reagent container is presented to the analyzer, and/or to alert an operator that results reported by the analyzer were obtained using a previously used reagent container and that the assay results may therefore be suspect.